Influence Factors and Cognitive Characteristics in Unipolar and Bipolar Depression:Based on the THINC-it Tool

NCT05053204 | Unknown

• 1 other identifier: PWRq2021-59
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive impairment is the core symptom of unipolar and bipolar depression, which seriously affects the prognosis of the disease and the rehabilitation of social function. There is no unified conclusion in the field and severity of cognitive impairment, and the cause of cognitive impairment is unknown, which may be related to many factors. In this study,the THINC-it tool was used to study the characteristics of cognitive impairment in unipolar and bipolar depression by longitudinal follow-up, which provides a theoretical basis for the differential diagnosis of unipolar and bipolar depression. Early identification and intervention of risk factors can improve the prognosis of the disease.

Conditions

Cognitive Impairments

Outcome Measures

Primary Outcomes (1)

• the THINC-it Tool

  The composite THINC-it tool score is the integrated total score of results from performance on five sub-component cognitive tests of the THINC-it tool.

  up to 12 week

Secondary Outcomes (3)

• HAMD-17

  up to 12 week

• HAM-A

  up to 12 week

• Pittsburgh Sleep Quality Index，PSQI

  up to 12 week

Study Arms (3)

unipolar depression group

In accordance with the diagnostic criteria of ICD-10 Unipolar depressive disorder, outpatients or inpatients in the Department of mood Disorders, Mental Health Center of Pudong New area.

bipolar depression group

In accordance with the diagnostic criteria of ICD-10 Bipolar depression , outpatients or inpatients in the Department of mood Disorders, Mental Health Center of Pudong New area.

healthy control group

Any mental disorder that does not meet the diagnosis of ICD-10, and the society recruits healthy controls who match the sex, age and education level of the patients in the case-group.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

According to the diagnostic criteria of ICD-10 Unipolar and bipolar depressive disorder, 40 patients with Major depressive disorder, 40 patients with bipolar depression and 40 healthy controls matched with the sex, age and education level of the patients in the case group served as healthy controls.

You may qualify if:

• Case group:
• 、Participants in psychiatric outpatients and inpatients are able and willing to provide informed consent.
• \. The participants were male or female aged between 18 and 60, with junior high school education or above.
• \. According to ICD-10 criteria, participants were diagnosed with Unipolar and bipolar depressive disorder.
• \. The total score of Young's Mania scale ((YMRS)) of the participants was less than 5 and HAMD-17 was greater than17.
• \. Subjects received stable mood stabilizers at least two weeks before the study visit, such as SSRIs antidepressants.
• \. The combination or use of supportive psychotherapy is allowed.
• Control group:
• it did not meet any of the diagnostic criteria in ICD-10 in the past or at present.
• years old, junior high school education or above. 3.Have sufficient audio-visual skills to complete the necessary examinations of the study.
• Willing to participate in this study, and the informed consent form was signed by the subjects.

You may not qualify if:

• Current alcohol and / or substance use disorders.
• Any drugs that may affect cognitive function, such as psychotropic stimulants, corticosteroids, and receptor blockers.
• Benzodiazepines were used within 12 hours and alcohol consumption within 8 hours before using the THINC-it tool.
• The patients have some serious physical conditions.
• The patients received electroconvulsive therapy ((ECT)) in the past 6 months.
• They are serious negative suicidal concepts and behaviors.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center IRB

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jun Chen, M.D., Ph.D

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Chen, M.D., Ph.D

CONTACT

021-34773367; doctorcj2010@gmail.com

Na Zhu

CONTACT

021-68306699; zhuna0552@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 22, 2021
• Study Start: May 15, 2021
• Primary Completion: October 30, 2022
• Study Completion: June 30, 2023
• Last Updated: September 14, 2022

Record last verified: 2021-09

Locations

CN (1)